Safety of Administering Pegfilgrastim on the Same Day of Continuously Infused 5-Fluorouracil (5-FU) for Patients with Gastrointestinal (GI) Malignancies: A Retrospective Study Público

Abstract

Purpose: 5-Fluorouracil (5-FU) is a common agent for treating patients with gastrointestinal (GI) malignancies. The primary objective of this study is to examine the safety of pegfilgrastim administration on the same day of continuous 5-FU infusion in regimens. 

 

Methods: Descriptive analysis was used to describe the demographic and clinical covariates. Risks and 95% confidence intervals were constructed to evaluate the safety of administering pegfilgrastim on the same day of 5-FU for all patients and for patients who received prior chemotherapy. Logistic regression was fitted to examine the risk factors for severe adverse events, including grade 3, grade 4 and febrile neutropenia, hospital admission, dose reduction and treatment delay. 

 

Results: Average age of patients of the study was 60.8. The risk of grade 4 and febrile neutropenia among all patients with GI malignancies was 0.007 (95% CI: 0.001, 0.024) while that for patients with prior chemotherapy was 0.000 since no patients reported experiencing such events. The risk of hospital admission was 0.017 (95% CI: 0.005-0.039) for all patients and the risk of that for patients with prior chemotherapy was 0.001 (95% CI: 0.000-0.053). The odds of grade 3 neutropenia for Caucasians was 0.14 (95% CI: 0.01-1.88) of that for African American. 

 

Conclusion: The risks of adverse events for patients with GI malignancies and for patients who had prior chemotherapy were low. Older patients were likely to have higher odds of experiencing severe adverse events. Racial difference was also observed for grade 3 neutropenia, where African American may have higher odds of experiencing it. Further studies would be needed to examine the effectiveness of administration of pegfilgrastim on the same day of continuous 5-FU infusion for patients with GI malignancies.

Table of Contents

1. Introduction ..................................................................................................................... 8 

2. Patients and Methods .................................................................................................... 10 

2.1 Study Design ........................................................................................................... 10 

2.2 Statistical Analysis .................................................................................................. 11 

2.2.1 Descriptive Summarization .............................................................................. 11 

2.2.2 Risk Analysis .................................................................................................. 12 

2.2.3 Logistic Regression .......................................................................................... 12 

3. Results (See Appendix)................................................................................................. 15 

3.1 Descriptive Summarization ..................................................................................... 15 

3.2 Risk Analysis .......................................................................................................... 15 

3.3 Univariable and Multivariable Logistic Regression Analysis ................................ 16 

4. Discussion and Conclusions ......................................................................................... 17 

5. Bibliography ................................................................................................................. 19 

6. Appendix: Figures and Tables ...................................................................................... 21 

About this Master's Thesis

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School	Rollins School of Public Health
Department	Biostatistics
Degree	M.P.H.
Submission	Master's Thesis
Language	English
Research Field	Statistics
Palavra-chave	Rare events analysis Clinical trial Pegfilgrastim
Committee Chair / Thesis Advisor	Chen, Zhengjia, Emory University
Committee Members	Kutner, Michael, Emory University
Partnering Agencies	Does not apply (no collaborating organization)

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